The 21st Century Cures, a wide-ranging bill that authorizes additional cancer research funding as well as funds for the US Food and Drug Administration (FDA) to streamline drug and device approval processes, passed the Senate on December 7 with a bipartisan backing of 94–5 and was signed into law by President Obama on December 13, 2016. While this effort has been lauded as a return to the more traditional give-and-take approach to legislation, many myeloma patients and caregivers remain unclear about how it will affect them. Since its introduction by Rep. Fred Upton (R-MI), much of the bill has been changed, added to or altered, leaving behind those who did not follow the changes closely. The IMF Advocacy Team would like to take this opportunity to highlight some of this bill’s main components.
National Institute of Health (NIH) and National Cancer Institute (NCI) Funding: The Bill authorizes $4.976 billion for the NIH Innovation Account over 10 years with $300 million allocated to the NCI for cancer research. This money would fund Vice President Joe Biden’s National Cancer Moonshot Initiative, the Precision Medicine and BRAIN Initiatives, and regenerative stem cell research. In a direct endorsement of Biden’s moonshot efforts, the first item in the nearly 1,000-page bill is named “Beau Biden Cancer Moonshot and NIH Innovation Projects,” an indication that the funds for cancer research are to be used for moonshot priorities.
NIH and NCI are “extremely fortunate” that support for research in Congress is bipartisan, said NCI Acting Director Doug Lowy at a joint meeting of the National Cancer Advisory Board and the Board of Scientific Advisors. “I want to point out that [the Cures Act] includes Blue Ribbon Panel recommendations, but it says specifically, ‘Research that has the potential to transform the scientific field that has inherently higher risk and that seeks to address major challenges associated with cancer.’ This actually is quite broad,” Lowy said at the meeting on December 6.
FDA’s Accelerated Drug Approvals: Of the $300 million allocated for the NCI, $15 million may be set aside for the FDA Oncology Center of Excellence, a moonshot initiative led by Richard Pazdur, director of the agency’s Office of Hematology and Oncology Products. Separately, $500 million has been diverted to the FDA to streamline the drug approval process. In considering whether to approve new drugs or new uses for medications, the bill says, the FDA shall pay more attention to “patient experience data” showing the impact of a disease or treatment on patients’ lives, and their treatment preferences.
Scott Whitaker, president and chief executive of the Advanced Medical Technology Association, a trade group for device makers, hailed the bill for creating “an expedited pathway for breakthrough medical technologies – those that offer the best hope for patients with life-threatening diseases” and few treatment options. In reviewing new devices, the bill says, the FDA shall consider the “least burdensome” means of showing their safety.
The approval of the Cures Act represents more than two years of information gathering, collaboration and a commitment from stakeholders across the research enterprise to accelerating medical progress, said Mary Woolley, president and CEO of Research!America. “The bill is a crucial step towards removing barriers to innovation, securing funding for major initiatives like the cancer moonshot and streamlining drug development to ensure more patients benefit more quickly from lifesaving therapies and devices,” Woolley said in a statement.
The Cures Act is not perfect, however. Missing from the nearly 1,000-page bill is an attempt to address the rising cost of treatment. “When the cost of our prescription drugs is skyrocketing, this bill does nothing to combat excessive prices,” said Rep. Rosa DeLauro (D-CT), the senior Democrat on the Appropriations subcommittee on health and human services. She voted against the measure.
Also missing from the bill is any guarantee of funding for each of the next 10 years. “While the bill authorizes $4.8 billion to the NIH over the next 10 years – on average, a mere $480 million a year – this is barely a quarter per year of what the House passed last year,” Ms. DeLauro said. “There is also no guarantee that the appropriators will follow through and provide funding each year.” Rep. Kathy Castor (D-FL), who voted for the bill, said she too wished that more of the money had been guaranteed. “Medical research in America today should not be subject to the whims of congressional budget battles or political fights,” she said.
If you would like more information on the 21st Century Cures Act, or have an interest in getting involved in patient advocacy, please contact Robin Levy, IMF Director of Public Policy and Advocacy, at email@example.com.